FDA on Phase IV trials

Executive Summary

The design and implementation of post-marketing commitments will be studied by an outside contractor as part of a new FDA initiative to evaluate and improve the Phase IV commitment process, according to Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb, MD. The intiative will "evaluate and perhaps improve how we use post-marketing commitments," Gottlieb said during an American Enterprise Institute discussion Feb. 8 in Washington, D.C. The agency currently is in negotiations and expects to announce the contract for the one-year study in the next few weeks. "The objectives of this effort are to evaluate the consistencies of the processes within the divisions, across divisions within FDA and also across different medical centers for requiring, requesting and facilitating as well as reviewing post-market commitments," Gottlieb said...